Programmed Death-1 (PD-1) Antibody Combined With Chemoradiotherapy in High-risk Recurrent Nasopharyngeal Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 15, 2023
  • participants needed
    68
  • sponsor
    Sun Yat-sen University
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Updated on 1 March 2022
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Summary

This is a a prospective, single-arm phase II clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemotherapy in high-risk recurrent nasopharyngeal carcinoma.

Details
Condition Recurrent Nasopharyngeal Carcinoma
Treatment IMRT, Chemotherapy, PD-1 blocking antibody
Clinical Study IdentifierNCT03930498
SponsorSun Yat-sen University
Last Modified on1 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment
Not suitable for surgery
Newly histologic diagnosis of NPC (WHO II/III)
Clinical stage rII-IVa (AJCC/UICC 8th)
ECOG 0-1 point
PRANCIS score > 252 points
No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy
No contraindications to immunotherapy or chemoradiotherapy
Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L
Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN
Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula)
Take effective contraceptions during and two months after treatment
Patients must be informed of the investigational nature of this study and give written informed consent

Exclusion Criteria

Have recurrence with local necrosis
Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa
Unexplained fever > 38.5 ℃, except for tumor fever
Treated with ≥ 5 days antibiotics one month before enrollment
Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy)
Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E3copiers/ml) or hepatitis C virus (HCV) antibody positive
Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway
Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment
Have known allergy to large molecule protein products or any compound of study therapy
Pregnant or breastfeeding
Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma
Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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